HEMATOPOIETIC BIOREPOSITORY AND CELLULAR THERAPY SHARED RESOURCE PROJECT SUMMARY/ABSTRACT The Hematopoietic Biorepository and Cellular Therapy Shared Resource (Hematopoietic SR) is an essential asset to Case Comprehensive Cancer Center (Case CCC) members' research, illustrated by the breadth of scientific program involvement and reflected in the large number of investigators who use this SR. Last year alone, over 50 investigators, 51% of whom were Case CCC members, accounting for 68% of total usage, from all 7 of the Center?s Programs used the SR. The mission of the Hematopoietic SR is to provide resources and services related to the procurement, processing, production, storage, banking, analysis and distribution of cells derived from human blood, bone marrow, and umbilical cords. The SR also operates a Clinical Cellular Therapy facility that supports clinical-grade cell manufacturing for investigational and standard of care therapy. The Specific Aims of the Hematopoietic SR are to: 1. Enable access to annotated clinical blood and bone marrow samples to support basic and translational research. An active IRB is maintained to consent and procure blood and bone marrow samples and related case and tissue data from cancer patients and healthy donors for distribution to Case CCC investigators. 2. Assist users with specialized hematopoietic cell assays. Guidance and services are provided to enable investigators to perform specialized hematopoietic cell assays such as colony assays. 3. Support the development and implementation of cellular therapy clinical trials. Support is provided in all aspects of clinical cell therapy, from assisting with regulatory approval to oversight and manufacture of clinical grade cells. At last review, the Hematopoietic SR was rated Excellent merit. Throughout the current funding cycle (2012- 2016), the Hematopoietic SR provided services to 106 registered users, 44 (42%) of whom are Case CCC members, representing all 7 of the Case CCC programs. The Hematopoietic SR maintains a biorepository of annotated collected samples for use in research and assists investigators with specialized hematopoietic assays such as CFU assays and bone marrow-derived mesenchymal stem cell isolation. The cellular therapy component of the SR, designated as the Cellular Therapy Service, supports clinical cellular therapy activities from the preclinical phase through clinical trial implementation. Support capabilities include assistance in the design and preparation of cells for Good Laboratory Practices (GLP) safety studies, navigation of the regulatory pathway, clinical protocol development, Investigational New Drug Application (IND) preparation, sourcing of clinical grade supplies and reagents, and scale up from research to clinical operations, including preparation of investigational clinical therapy grade cellular products.